<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20240711062391N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-02-16</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Effect of family-centered distance Nurse-led health literacy training on symptom burden and readmission of patients with ischemic heart disease after discharge</public_title>
      <acronym></acronym>
      <scientific_title>Effect of family-centered distance Nurse-led health literacy training on symptom burden and readmission of patients with ischemic heart disease after discharge</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/88861</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The present study will be a two-group before-and-after clinical trial study. The research units will be selected conveniently and randomly assigned to the intervention and control groups using the alternating block randomization technique. Blocks of 4 with 6 conditions will be used. The letter A will indicate the participant in the intervention group and the letter B will indicate the participant in the control group. The samples in the two intervention and control groups will be assigned to the intervention and control groups based on the sequence of entry and according to the block pattern that is randomly selected from the blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Health Literacy, Symptom Burden, Readmission.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: During the study, caregivers in the intervention group will receive routine caregiving training provided in the intensive care unit. In addition, caregivers in the intervention group will receive health literacy training in the field of ischemic heart disease in the form of a written program led remotely by a nurse. This program will include educational sessions on improving health literacy in the field of ischemic heart disease, which will be presented via the sky room platform in the form of lectures and questions and answers during 6 sessions. One session will be held each week for 45-60 minutes, which will include discussions and strategies related to improving health literacy in the field of previous ischemic disease and how to manage treatment and care. During the 6 weeks of the intervention, telephone text messages will be sent once a week to the research units to ensure that the desired intervention is received.In an educational channel, an educational message on the topics presented will be sent three times a week at a specific time on an internal platform that includes members of the research team and research units. Data collection will be carried out before and 3 months after the start of the intervention using a demographic data checklist, an adult health literacy questionnaire, the Edmonton symptom scale, and a patient readmission survey through contact with the caregiver. In order to facilitate data collection in the post-intervention phase through the press line, questionnaires will be designed and provided to participants for completion. Intervention 2: Control group: During the study, caregivers in the control group will receive routine caregiving training provided in the intensive care unit. Data collection will be conducted before and 3 months after the intervention using a demographic data checklist, the Adult Health Literacy Assessment Questionnaire, the Edmonton Symptom Scale, and a patient readmission survey by contacting the caregiver. In order to facilitate data collection in the post-intervention phase through the Pressline, questionnaires will be designed and provided to participants for completion.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Erfan Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahamat 2 Alley, Shahamat St., Moshaver Town, Arak, IRAN</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3818887174</zip>
        <telephone>+98 86 3368 8149</telephone>
        <email>erfanmohammadiuniversity@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behzad Hamedani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardasht, Basij Square, Prophet Muhammad (PBUH) University Complex, Blue Wing Nursing School, 3rd floor, Units 227 and 400</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 3383 8227</telephone>
        <email>b.hamedani@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being literate
Having a mobile phone and the ability to use social networks and smartphones
Diagnosis of ischemic heart disease by a specialist physician and recording in the patient's file
The caregiver of the research participant should be the patient's primary caregiver
At least 6 months have passed since the diagnosis of the disease</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence of cognitive and psychological problems in the patient's caregiver with questioning
Caregiver's lack of participation in other similar educational programs and self-care methods in the past 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: During the study, caregivers in the intervention group will receive routine caregiving training provided in the intensive care unit. In addition, caregivers in the intervention group will receive health literacy training in the field of ischemic heart disease in the form of a written program led remotely by a nurse. This program will include educational sessions on improving health literacy in the field of ischemic heart disease, which will be presented via the sky room platform in the form of lectures and questions and answers during 6 sessions. One session will be held each week for 45-60 minutes, which will include discussions and strategies related to improving health literacy in the field of previous ischemic disease and how to manage treatment and care. During the 6 weeks of the intervention, telephone text messages will be sent once a week to the research units to ensure that the desired intervention is received.In an educational channel, an educational message on the topics presented will be sent three times a week at a specific time on an internal platform that includes members of the research team and research units. Data collection will be carried out before and 3 months after the start of the intervention using a demographic data checklist, an adult health literacy questionnaire, the Edmonton symptom scale, and a patient readmission survey through contact with the caregiver. In order to facilitate data collection in the post-intervention phase through the press line, questionnaires will be designed and provided to participants for completion.</i_keyword>
      <i_keyword>Control group: During the study, caregivers in the control group will receive routine caregiving training provided in the intensive care unit. Data collection will be conducted before and 3 months after the intervention using a demographic data checklist, the Adult Health Literacy Assessment Questionnaire, the Edmonton Symptom Scale, and a patient readmission survey by contacting the caregiver. In order to facilitate data collection in the post-intervention phase through the Pressline, questionnaires will be designed and provided to participants for completion</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduction in Edmonton symptom score. Timepoint: Before and 3 months after the start of the intervention. Method of measurement: Edmonton Symptom Assessment Scale.</prim_outcome>
      <prim_outcome>Reduction in the number of readmissions. Timepoint: Before and 3 months after the start of the intervention. Method of measurement: Readmission of patients after discharge within 1 month of follow-up.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-23</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Arak University of Medical Sciences, Basij St, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
